Moldy Odor Leads To Expanded J&J Recall

January 16, 2010

Johnson & Johnson is recalling over 53 million bottles of its over-the-counter products for the second time in less than a month, reported the Associated Press.

The American pharmaceutical manufacturer chose to implement the latest recall after hearing consumer reports of “an unusual moldy, musty, or mildew-like odor that, in a small number of cases, was associated with temporary and non-serious gastrointestinal events,” the company said. Symptoms included nausea, stomach pain, vomiting and diarrhea.

This recall has broadened to include some batches of regular and extra-strength Tylenol, children’s Tylenol, eight-hour Tylenol, Tylenol arthritis, Tylenol PM, children’s Motrin, Motrin IB, Benadryl Rolaids, Simply Sleep, and St. Joseph’s aspirin. Products in both caplet and geltab form were recalled after being sold in the Americas, the United Arab Emirates, and Fiji were recalled.

In November, the company’s McNeil Consumer Healthcare Products recalled some Tylenol Arthritis Caplets because of the odor, which caused some consumers to become sick. Almost three weeks ago, the company expanded its recall to include Tylenol Arthritis Caplets.

Federal regulators were up in arms over the way the company handled the recall, saying that McNeil was too slow in responding to the problem.

Though McNeil was aware of the issue in early 2008, the Food and Drug Administration (FDA) says it made only a limited investigation.

According to the FDA, about 70 people had either noticed the smell, or had become sick from it.

“McNeil should have acted faster,” said Deborah Autor, the director of the FDA’s Office of Compliance of the Center for Drug Evaluation and Research.

“When something smells bad, literally or figuratively, companies must aggressively investigate and take all necessary action to solve the problem.”

The agency sent McNeil a warning letter for its violation of manufacturing standards and for not promptly reporting and investigating the problem, Autor said.

Johnson & Johnson has 15 days to respond to the letter, and the FDA wants the company to explain why it took them so long to make the problem public.

So far, the company says there have not been any reports of sickness related to the recent recall, but McNeil said the expanded recall includes product lots that could be affected by the same problems of nausea.

The source of the smell is from a small amount of chemicals associated with the treatment of wooden pallets, said the company. The FDA said the chemical can seep into the air, and the agency traced it to a facility in Las Piedras, Puerto Rico.

Johnson and Johnson said it is working with the FDA and is currently looking into the issue, halting product shipment that has the same materials on wooden pallets. Suppliers have been asked to do the same.

Federal prosecutors in Boston said on Friday that Johnson & Johnson paid tens of millions of dollars in kickbacks so that nursing homes would prescribe more of its popular schizophrenia drug.

The complaints coming from the government states that J&J offered special rebates to Omnicare Inc., the largest dispenser of prescription drugs to nursing homes in the nation. In return, the nursing home pharmacists would recommend that the patients be given Risperdal, in many cases when it was not appropriate.

In a statement, J&J said it “will address the government’s lawsuit in court” and contends that its rebates were “lawful and appropriate.”